A Case of Varicella Zoster and Mpox Coinfection in a Patient Living With HIV.

ABSTRACT: We present a case of recurrent, cutaneous mpox with coinfection of disseminated varicella zoster in an immunocompromised patient with poorly controlled HIV. This case demonstrates the importance of maintaining a high index of suspicion for mpox despite prior infection and vaccination, as suboptimal immune response is possible in immunocompromised patients, and also noting the potential for coinfection necessitating timely diagnosis and appropriate testing.

Microbial interactions among Gardnerella, Prevotella and Fannyhessea prior to incident bacterial vaginosis: protocol for a prospective, observational study.

INTRODUCTION: The aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria. Gardnerella spp are present in 95%-100% of cases; Gardnerella vaginalis has been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However, G. vaginalis is found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise that Gardnerella spp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie, Prevotella bivia, Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV. METHODS AND ANALYSIS: This study will enrol 150 women aged 18-45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR for Gardnerella spp, P. bivia and F. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7-10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity. ETHICS AND DISSEMINATION: This protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.

Challenges in Male Partner Referral Among Trichomonas vaginalis -Infected Women.

ABSTRACT: This study assessed feasibility of male partner referral by Trichomonas vaginalis -infected women. Of 93 women approached, only 20 enrolled. Only 1 male partner contacted the study but was unable to be reached for scheduling. Other public health interventions are necessary to engaged T. vaginalis -infected women and their male partners in care.

Bacterial Vaginosis in Postmenopausal Women.

Purpose of Review: Bacterial vaginosis (BV) is the most common vaginal infection worldwide, but most research has been conducted in premenopausal women. After menopause, endogenous estrogen production decreases, often leading to the genitourinary syndrome of menopause (GSM), characterized by vulvovaginal dryness and irritation. The estrogen-deficient postmenopausal state results in an elevated vaginal pH and depletion of vaginal lactobacilli. Use of traditional BV diagnostics (Amsel criteria, Nugent score) is difficult in post-menopausal women, especially those not on estrogen replacement therapy, as these methods were originally developed in premenopausal women. In this review, we discuss recent clinical data on BV in postmenopausal women, difficulties in diagnosis using traditional methods, the role of BV molecular diagnostics, and our current expert opinion for managing BV in this population. Recent Findings: BV prevalence has been found to range between 2%-57% among postmenopausal women per Amsel and Nugent criteria. This is likely an over-estimate of the true prevalence due to limitations in these criteria which were only validated in pre-menopausal women. Despite increasing diagnostic options for BV in recent years, including highly sensitive and specific BV nucleic acid amplification tests (NAATs), the physiologic changes of menopause and limited inclusion of postmenopausal women in clinical studies, diagnosis is difficult in this population. Recent studies utilizing 16s rRNA gene sequencing suggest that the vaginal microbiota of premenopausal and postmenopausal women is quite different, even if BV is not present. Data also suggest that obese postmenopausal women have significantly lower rates of BV compared to non-obese postmenopausal women, although further research is needed in this area. Multiple treatment options exist for vaginal atrophy and BV in this population. Summary: Data are limited regarding optimal diagnostic approaches for BV in postmenopausal women; BV NAATs and 16s rRNA gene sequencing may have a role for diagnosing BV in symptomatic women although further studies are needed. Menopausal women with characteristic vaginal symptoms and an elevated vaginal pH should be initially treated for estrogen deficiency prior to considering a diagnosis of BV; subsequent treatment for BV should be driven by symptoms.

Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data.

OBJECTIVES: Bacterial vaginosis (BV) and trichomoniasis are the most common causes of vaginitis. Both infections are associated with increased risk of acquisition and transmission of HIV and other sexually transmitted infections as well as adverse reproductive health outcomes. Co-infection is common, with rates ranging from 60% to 80%. We evaluated the efficacy of single-dose oral secnidazole 2 g for the treatment of trichomoniasis in a subgroup of women co-infected with BV and trichomoniasis. DESIGN: Post hoc analysis of data from a phase 3 randomised, double-blind, placebo-controlled, delayed-treatment study. SETTING: 10 centres in the USA. PARTICIPANTS: Subgroup of women (aged ≥12 years) with a confirmed diagnosis of Trichomonas vaginalis and co-infection with BV clinically diagnosed using Amsel's criteria. INTERVENTION: Single dose of secnidazole 2 g or placebo. OUTCOME MEASURES: The primary efficacy outcome was the microbiological cure (negative culture for T. vaginalis) at the test of cure (TOC) visit 6-12 days after dosing in the modified intent-to-treat population (mITT). At TOC, participants received the opposite treatment. RESULTS: Of the 131 T. vaginalis-infected participants in the mITT, 79 (60.3%) met ≥3 Amsel's criteria for BV at enrolment. Microbiological cure rates for trichomoniasis at TOC among this subgroup of women were 97.7% (42/43) for secnidazole and 0% (0/36) for placebo. CONCLUSION: Single-dose oral secnidazole 2 g was highly efficacious in curing trichomoniasis in women co-infected with BV. Appropriate and effective treatment options for co-infection are essential for reducing transmission and reinfection. Secnidazole is the only single-dose medication approved by the Food and Drug Administration for the treatment of BV in women and trichomoniasis in women and men. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03935217; post-results.

Sexual healthcare and at-home STI test collection: attitudes and preferences of transgender women in the Southeastern United States.

Background: HIV and sexually transmitted infections (STIs) disproportionally affect transgender women in the United States, particularly in the Southeast where rates of HIV and bacterial STIs are especially high. Despite the high HIV/STI burden among transgender women, their engagement in sexual healthcare services, including HIV/STI testing, is low. Understanding reasons for this disconnect is essential in developing HIV/STI prevention efforts for this population, especially in the Southeastern US, where access to affirming sexual healthcare providers and resources is limited. We aimed to perform an exploratory qualitative study to describe the attitudes and preferences of transgender women living in Alabama with regards to sexual healthcare and at-home STI test collection. Methods: Transgender women ≥18 years old residing in Alabama were invited to participate in virtual individual in-depth interviews via Zoom. The interview guide explored participant experiences engaging with sexual healthcare services as well as preferences related to extragenital (i.e., rectal, pharyngeal) and at-home STI testing for gonorrhea and chlamydia. A trained qualitative researcher coded transcripts after each interview and iteratively amended the interview guide as themes emerged. Data were coded and thematically analyzed using NVivo qualitative software. Results: Between June 2021-April 2022, 22 transgender women were screened and 14 eligible women enrolled. Eight participants were white (57%), and six were black (43%). Five participants (36%) were living with HIV and engaged with HIV care services. Interview themes included preference for sexual healthcare environments specializing in LGBTQ+ care, enthusiasm toward at-home STI testing, an emphasis on affirming patient-provider interactions in sexual healthcare settings, a preference for sexual healthcare providers involved in STI testing who were not cisgender men, and gender dysphoria around sexual health discussions and testing. Conclusion: Transgender women in the Southeastern US prioritize affirming provider-patient interactions, however resources in the region are limited. Participants were enthusiastic about at-home STI testing options, which have the potential to mitigate gender dysphoria. Further investigation into development of remote sexual healthcare services for transgender women should be performed.

Why Wait? The Ethics of Disclosing HIV Screening Results.

Counseling patients on their HIV test results is an important part of undergraduate and graduate medical education. However, many trainees and physicians feel ill prepared to counsel patients on potentially distressing results. We present a case involving early disclosure of a false-positive HIV screening test result to a patient and the downstream effects of this premature disclosure. This case highlights the importance of understanding the various HIV testing options available and the importance of education on effectively counseling patients on screening versus confirmatory HIV test results.

Trichomoniasis.

Trichomoniasis is the most common nonviral sexually transmitted infection worldwide. It has been associated with a variety of adverse sexual and reproductive health outcomes for both men and women. In this review, the authors discuss updates in its epidemiology, pathophysiology, clinical significance, diagnosis, and treatment.

Providing gender-affirming care to transgender and gender-diverse individuals with and at risk for HIV.

Transgender and gender-diverse populations have unique medical and psychosocial needs. It is important that clinicians address these needs with a gender-affirming approach in all aspects of health care for these populations. Given the significant burden of HIV experienced by transgender people, such approaches in providing HIV care and prevention are essential both to engage this population in care and to work toward ending the HIV epidemic. This review presents a framework for practitioners caring for transgender and gender-diverse individuals to deliver affirming, respectful health care in HIV treatment and prevention settings.

Impact of testosterone use on the vaginal microbiota of transgender men, including susceptibility to bacterial vaginosis: study protocol for a prospective, observational study.

INTRODUCTION: The effect of testosterone (T) therapy on the vaginal microbiota of transgender men (TGM) is not well characterised, although one cross-sectional study comparing the vaginal microbiota of cisgender women to TGM on T≥1 year found that, in 71% of the TGM, the vaginal microbiota was less likely to be Lactobacillus-dominated and more likely to be enriched with >30 other bacterial species, many associated with bacterial vaginosis (BV). This prospective study aims to investigate changes in the composition of the vaginal microbiota over time in TGM who retain their natal genitalia (ie, vagina) and initiate T. In addition, we will identify changes in the vaginal microbiota preceding incident BV (iBV) in this cohort while investigating behavioural factors, along with hormonal shifts, which may be associated with iBV. METHODS AND ANALYSIS: T-naïve TGM who have not undergone gender-affirming genital surgery with normal baseline vaginal microbiota (ie, no Amsel criteria, normal Nugent Score with no Gardnerella vaginalis morphotypes) will self-collect daily vaginal specimens for 7 days prior to initiating T and for 90 days thereafter. These specimens will be used for vaginal Gram stain, 16S rRNA gene sequencing and shotgun metagenomic sequencing to characterise shifts in the vaginal microbiota over time, including development of iBV. Participants will complete daily diaries on douching, menses and behavioural factors including sexual activity during the study. ETHICS AND DISSEMINATION: This protocol is approved through the single Institutional Review Board mechanism by the University of Alabama at Birmingham. External relying sites are the Louisiana State University Health Sciences Center, New Orleans Human Research Protection Program and the Indiana University Human Research Protection Program. Study findings will be presented at scientific conferences and peer-reviewed journals as well as shared with community advisory boards at participating gender health clinics and community-based organisations servicing transgender people. REGISTRATION DETAILS: Protocol # IRB-300008073.

The Relationship Between HIV Pre-exposure Prophylaxis Stigma and Treatment Adherence Among Current HIV Pre-exposure Prophylaxis Users in the Southeastern U.S.

Despite efficacy in HIV prevention, Pre-exposure Prophylaxis (PrEP) is underutilized in the US, especially among populations at highest risk. PrEP-related stigma may play a role. We developed measures of PrEP-related stigma dimensions and PrEP adherence. We administered them to current PrEP users. We hypothesized that PrEP-related stigma would negatively impact PrEP adherence. Questionnaire measures were developed using data from previous qualitative work and existing validated HIV-related stigma measures. The resultant survey was administered to current PrEP users from two Birmingham, Alabama PrEP clinics. Plasma tenofovir disoproxil fumarate levels were collected to measure PrEP adherence. Exploratory factor analyses were performed to determine the factor structure of each PrEP-related stigma dimension (internalized, perceived, experienced, anticipated, disclosure concerns). Separate binary logistic (or linear) regressions were performed to assess associations between PrEP-related stigma dimensions and adherence (treatment adherence self-efficacy, self-reported adherence, and plasma tenofovir levels), adjusting for education, race, and time on PrEP. In 2018, 100 participants completed the survey, with 91 identifying as male and 66 as white. Only internalized stigma was associated with lower self-reported PrEP adherence. Exploratory mediation analyses suggested that the association between all stigma dimensions and self-reported PrEP adherence is mediated by PrEP adherence self-efficacy. No associations were found between any PrEP-related stigma measures and plasma tenofovir levels. Internalized PrEP stigma may reduce PrEP adherence, possibly by reducing PrEP adherence self-efficacy among experienced PrEP users. Further investigation of how stigma dimensions affect PrEP adherence in populations at risk for HIV may shed light on drivers of PrEP underutilization.

Sexually transmitted infections and female reproductive health.

Women are disproportionately affected by sexually transmitted infections (STIs) throughout life. In addition to their high prevalence in women, STIs have debilitating effects on female reproductive health due to female urogenital anatomy, socio-cultural and economic factors. In this Review, we discuss the prevalence and impact of non-HIV bacterial, viral and parasitic STIs on the reproductive and sexual health of cisgender women worldwide. We analyse factors affecting STI prevalence among transgender women and women in low-income settings, and describe the specific challenges and barriers to improved sexual health faced by these population groups. We also synthesize the latest advances in diagnosis, treatment and prevention of STIs.

Secnidazole: a treatment for trichomoniasis in adolescents and adults.

INTRODUCTION: Single-dose 2-g oral secnidazole (SEC), newly approved by the U.S. Food and Drug administration (FDA) for treatment of trichomoniasis, is a potent 5-nitroimidazole with selective toxicity against various micro-organisms. It has been used internationally to treat trichomoniasis, bacterial vaginosis, and other infections for decades. Trichomoniasis is the most common non-viral sexually transmitted infection worldwide and is associated with significant morbidity. In comparison to the only other FDA-approved treatments for trichomoniasis in the United States - metronidazole and tinidazole - SEC has favorable pharmacokinetics, including a longer half-life and a lower minimal lethal concentration. AREAS COVERED: This work summarizes the chemistry and pharmacology of SEC and reviews the evidence on its efficacy, tolerability, and safety for the treatment of trichomoniasis. EXPERT OPINION: SEC is an efficacious, well tolerated, and safe treatment for patients aged ≥12 years with trichomoniasis. Single-dose administration makes it a favorable treatment option, especially in cases where adherence to multi-dose treatment regimens may be low.

Secnidazole for Trichomoniasis in Women and Men.

INTRODUCTION: Secnidazole (SEC), newly FDA-approved for trichomoniasis, is a potent 5-nitroimidazole with selective toxicity against various infections. It has been used internationally to treat trichomoniasis, bacterial vaginosis, and other infections for decades. Trichomoniasis is the most common non-viral sexually transmitted infection worldwide and is associated with significant morbidity. In comparison to the only other approved treatments for trichomoniasis in the U.S.-metronidazole and tinidazole-SEC has favorable pharmacokinetics, including a longer half-life, and a lower minimal lethal concentration against Trichomonas vaginalis. OBJECTIVES: Provide an updated, comprehensive review of the literature evaluating SEC as a treatment for trichomoniasis in women and men. METHODS: We conducted a search to identify existing research on SEC and trichomoniasis. On August 6, 2021, we searched MEDLINE using the terms "secnidazole" and "trichomon.*" We excluded reviews, editorials, case reports, and small case series. RESULTS: We identified 29 articles; 14 of which were included: 5 reported in vitro pharmacologic data on SEC, 6 were observational studies, and 4 were controlled clinical trials (1 observational study also reported in vitro pharmacologic data). Six studies reported data on women only, 1 on men only, and 3 on women and men. These studies showed that SEC-as a single dose or 3-day course-had comparable efficacy to multi-dose metronidazole for treating trichomoniasis in women and men, was generally well tolerated by patients, and had a favorable pharmacokinetic profile. A single 2-g dose of SEC also led to a microbiologic cure rate of 92.2% in the first randomized, double-blind, placebo-controlled study of trichomonas-infected US-based women. CONCLUSION: SEC is an efficacious and safe treatment for women and men with trichomoniasis. Single-dose administration makes it a favorable treatment option for patients, especially in cases where adherence to other multi-dose treatment regimens could be problematic. Christina A. Muzny and Olivia T. Van Gerwen. Secnidazole for Trichomoniasis in Women and Men. Sex Med Rev 2022;10:255-262.

"It's behaviors, not identity": Attitudes and beliefs related to HIV risk and pre-exposure prophylaxis among transgender women in the Southeastern United States.

HIV prevalence is high among transgender women (TGW) in the Southeastern U.S. Uptake of HIV Pre-Exposure Prophylaxis (PrEP) is low among TGW nationwide. We aimed to explore beliefs associated with PrEP among TGW in the Southeastern U.S., framed by the Health Belief Model. HIV-negative TGW ≥18 years old in Alabama participated in virtual focus group discussions. Authors coded and amended transcripts to explore emerging themes. Between July-December 2020, 17 TGW participated in 4 sessions. Mean age was 28.1±8.5 years. Several themes were identified: frustration with conflation of transgender identity and HIV risk, inappropriate transgender representation in PrEP advertising, concerns for interactions between PrEP and hormone therapy, perception that PrEP is meant for cisgender men who have sex with men and limited trans-affirming healthcare. Nuanced messaging is necessary to properly educate and engage TGW in HIV prevention strategies including PrEP given the diversity of this population.

Anatomical and sexual health considerations among transfeminine individuals who have undergone vaginoplasty: A review.

As acceptance of transgender and gender diverse individuals continues to increase, gender-affirming surgery, a cornerstone in the management of gender dysphoria, is becoming more readily available. HIV and sexually transmitted infections (STIs) disproportionately affect these populations, but there are limited epidemiologic and management data on STIs in people who have undergone gender-affirming genital surgery such as vaginoplasty. This review will provide clinicians with anatomical details about the various vaginoplasty procedures currently being performed, complications associated with these procedures, and an overview of the current literature describing HIV/STI epidemiology among transfeminine individuals who have undergone vaginoplasty.

Human Immunodeficiency Virus/Sexually Transmitted Infection Testing Preferences for Young Black Men Who Have Sex With Men in the Southeastern United States: Implications for a Post-COVID-19 Era.

BACKGROUND: Little is known regarding human immunodeficiency virus (HIV)/sexually transmitted infection (STI) testing preferences for location, staffing, and hours of operation among Young Black men who have sex with men (YBMSM) in the Southeastern United States, a population at high risk for HIV/STIs. We used a discrete choice experiment to explore these preferences. METHODS: Young Black men who have sex with men ages 16 to 35 years in Birmingham, AL and Jackson, MS completed online surveys evaluating their preferences (best/worst) for HIV/STI testing locations, staffing, hours, method of results notification, and cost. They also selected preferred combinations of these variables through choice tasks. Results were analyzed using joint best/worst and discrete choice experiment models. RESULTS: Between June 2018 and December 2019, participants in Alabama (n = 54) and Mississippi (n = 159) completed online surveys. Both groups preferred stationary testing locations over mobile testing vans, with the most significant difference favoring STI testing-only clinics in Mississippi and local health departments in Alabama (P < 0.001). Technician-performed tests or self-testing were significantly less preferred compared with clinician-performed testing for both groups (P < 0.0001 and P < 0.0001, respectively). Free testing and phone results notification (versus text) were preferred by both groups. The most desirable combination among all participants was weekday clinician-performed testing at the health department for $5. CONCLUSIONS: Young Black men who have sex with men in the Southeastern United States prefer traditional testing locations staffed by experienced personnel. Combination choices are influenced by services that are low or no cost. More research is needed to inform the best way(s) to provide affordable, high-quality HIV/STI testing services for YBMSM, particularly in the post-COVID-19 era when sexual health care delivery models are evolving toward home-based and remote health-focused strategies.

Epidemiology, Natural History, Diagnosis, and Treatment of Trichomonas vaginalis in Men.

Trichomonas vaginalis infections in men are traditionally considered to be benign and consequently have been overlooked. However, men with this common sexually transmitted infection can experience urethritis, prostatitis, reduced fertility, and amplified human immunodeficiency virus risk. In addition, men are often asymptomatic and can unknowingly spread the infection to their female sexual partners. With advances in T. vaginalis diagnostics, more men are being diagnosed, yet the optimal method of treatment in men remains unknown. The purpose of this review is to discuss the epidemiology, natural history, diagnosis, and treatment of T. vaginalis among men.

Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study.

BACKGROUND: Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis. METHODS: Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2 g or placebo. The primary endpoint was microbiological test of cure (TOC) by culture 6-12 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits, if needed. Fifty patients per group (N = 100) provided approximately 95% power to detect a statistically significant difference between treatment groups. RESULTS: Between April 2019 and March 2020, 147 women enrolled at 10 sites in the United States. The modified intention-to-treat (mITT) population included 131 randomized patients (secnidazole, n = 64; placebo, n = 67). Cure rates were significantly higher in the secnidazole vs placebo group for the mITT population (92.2% [95% confidence interval {CI}: 82.7%-97.4%] vs 1.5% [95% CI: .0%-8.0%]) and for the per-protocol population (94.9% [95% CI: 85.9%-98.9%] vs 1.7% [95% CI: .0%-8.9%]). Cure rates were 100% (4/4) in women with human immunodeficiency virus (HIV) and 95.2% (20/21) in women with bacterial vaginosis (BV). Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea (each 2.7%). No serious TEAEs were observed. CONCLUSIONS: A single oral 2 g dose of secnidazole was associated with significantly higher microbiological cure rates vs placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and/or BV. CLINICAL TRIALS REGISTRATION: NCT03935217.